Data and Safety Monitoring

Beckman Research Institute/City Of Hope, Duarte CA

Investigators

Linked publications, trials & patents

Abstract

The goal of Data and Safety Monitoring (DSM) at City of Hope (COH) is to provide oversight of clinical trials conducted at City of Hope Comprehensive Cancer Center independent of the protection of human subjects afforded through the COH Institutional Review Board (IRB) and the scientific review afforded through the Protocol Review and Monitoring System via the Cancer Protocol Review and Monitoring Committee (CPRMC). This function is organized around the Cancer Center's Data and Safety Monitoring Board (DSMB). The principal role of the DSMB is to review all protocol-specific data and safety monitoring plans, periodic reports from protocol management teams, deviation reports, and adverse event reports from investigators as they are submitted to determine the scientific impact of these toxicities on the conduct of the clinical trial in which they occurred. In addition, the DSMB regularly reviews audits of ongoing, high-risk, institutional cancer clinical trials for compliance with federal regulations and Good Clinical Practice (GCP) guidelines. Staff members of the Office of Clinical Research Quality Assurance (OCRQA) perform both detailed audits of ongoing in-house studies as part of the institution's clinical research quality assurance program as well as providing effective reporting of deviations in the conduct of all cancer clinical trials as they may occur. This level of review provides an independent means of confirming the efficacy of the investigational treatment programs ongoing in the Cancer Center. The total annual budget for DSM (5.42 FTEs) is $ 450,592; CCSG funding is requested for $ 59,749, or 13% of the total.